The Indian Pharmacopoeia Commission (IPC), an autonomous institution under the Ministry of Health and Family Welfare, Government of India, organized a two-day National Conference on “Quality and Safety of Biosimilars: Strengthening India’s Biopharma SHAKTI Vision” on September 10–11, 2026, at the Centre for Cellular and Molecular Platforms (C-CAMP), Bengaluru. 

The conference aligns with the Government of India’s Biopharma SHAKTI Vision to strengthen India’s biopharmaceutical ecosystem through innovation, self-reliance, quality, and global competitiveness. The conference addressed key scientific and regulatory challenges associated with the development, evaluation, and safety of biosimilars, with emphasis on pharmacopoeial standards, critical quality attributes, analytical characterization, comparability assessment, immunogenicity, pharmacovigilance, and evolving regulatory expectations. 

A major highlight of the conference was the release of the Indian Pharmacopoeia Reference Substance (IPRS) for Enoxaparin Sodium for bioassays. Enoxaparin Sodium is a low-molecular-weight heparin and anticoagulant widely used for the prevention and treatment of thromboembolic disorders. The IPRS for Enoxaparin Sodium for bioassays may serve as an authenticated reference material for bioassay testing, supporting accurate, consistent, and comparable assessment of its biological activity. 

The release of the IPRS marks an important advancement in strengthening the availability of authenticated pharmacopoeial reference substances for bioassay-related testing of Enoxaparin Sodium, while contributing to the Atmanirbhar Bharat vision by strengthening India’s indigenous pharmaceutical quality infrastructure.

Addressing the participants, Dr. V. Kalaiselvan, Secretary-cum-Scientific Director, IPC, highlighted the importance of strengthening pharmacopoeial standards, reliable analytical evaluation, safety monitoring, and regulatory cooperation to ensure the quality and safety of biosimilars. He also emphasized the need to align Indian practices with evolving regulatory expectations, support biopharmaceutical innovation, and contribute to the vision of Viksit Bharat.

In pursuit of the vision of Viksit Bharat, the conference seeks to advance harmonized standards and strengthen quality, safety, innovation, and regulatory excellence in the biopharmaceutical sector. The release of the IPRS for Enoxaparin Sodium for bioassays, together with the scientific deliberations, underscores IPC’s continued commitment to strengthening India’s pharmaceutical and biopharmaceutical quality infrastructure and fostering collaboration among regulators, industry, academia, and research institutions to support innovation and enhance regulatory confidence.

The conference was attended by 160 participants from regulatory authorities, industry, academia, research organizations and other stakeholder groups. The conference was organized by IPC in collaboration with Indian Drug Manufacturers’ Association (IDMA), Biotechnology Industry Research Assistance Council (BIRAC), Centre for Cellular and Molecular Platforms (C-CAMP) serving as Knowledge Partner, and Karnataka Drugs and Pharmaceuticals Manufacturers’ Association (KDPMA) as Associate Partner.